AVELOX 400/250 Mg/Ml Solution for Infusion

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

MOXIFLOXACIN HYDROCHLORIDE

Dostopno od:

Bayer Limited

Koda artikla:

J01MA14

INN (mednarodno ime):

MOXIFLOXACIN HYDROCHLORIDE

Odmerek:

400/250 Mg/Ml

Farmacevtska oblika:

Solution for Infusion

Tip zastaranja:

Product subject to prescription which may not be renewed (A)

Terapevtsko območje:

Fluoroquinolones

Status dovoljenje:

Authorised

Datum dovoljenje:

2007-11-02

Navodilo za uporabo

17093
PACKAGE LEAFLET: INFORMATION FOR THE USER
AVELOX 400 MG/250 ML SOLUTION FOR INFUSION
For use in adults.
Moxifloxacin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or
nurse.

If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Avelox is and what it is used for
2.
What you need to know before you are administered Avelox
3.
How to use Avelox
4.
Possible side effects
5.
How to store Avelox
6.
Contents of the pack and other information
1.
WHAT AVELOX IS AND WHAT IT IS USED FOR
Avelox contains the active substance moxifloxacin which belongs to a
group of antibiotics called
fluoroquinolones. Avelox works by killing bacteria that cause
infections if they are caused by bacteria
that are susceptible to moxifloxacin.
Avelox is used in adults for treating the following bacterial
infections:

Infection of the lungs (pneumonia) acquired outside the hospital

Infections of the skin and soft tissue
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE ADMINISTERED AVELOX
Contact your doctor if you are not sure if you belong to a patient
group described below.
DO NOT USE AVELOX

If you are allergic to the active substance moxifloxacin, any other
quinolone antibiotics or any
of the other ingredients of this medicine (listed in section 6).

If you are pregnant or breast-feeding.

If you are under 18 years of age.

If you have a history of tendon disease or disorder which was related
to treatment with
quinolone antibiotics (see sections _Warnings and precautions _and_ 4.
Possible side effects_).

If you were born with or have had any condition with abnormal heart
rhythm (seen on ECG,
electrical recording of the heart), have salt imbalance in the blood
(especially low level of
potassium or ma

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Avelox 400 mg/250 ml solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 bag of 250 ml contains 400 mg moxifloxacin (as hydrochloride).
1 ml contains 1.6 mg moxifloxacin (as hydrochloride).
Excipient with known effect: 250 ml of solution for infusion contains
787 mg (34 mmol) sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion
Clear, yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Avelox is indicated for the treatment of:
-
Community acquired pneumonia (CAP)
-
Complicated skin and skin structure infections (cSSSI)
Moxifloxacin should be used only when it is considered inappropriate
to use antibacterial agents that
are commonly
recommended for the initial treatment of these infections.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 400 mg moxifloxacin, infused once daily.
Initial intravenous treatment may be followed by oral treatment with
moxifloxacin 400 mg tablets, when clinically
indicated.
In clinical studies most patients switched to oral therapy within 4
days (CAP) or 6 days (cSSSI). The recommended
total duration of intravenous and oral treatment is 7 - 14 days for
CAP and 7 - 21 days for cSSSI.
_Renal/hepatic impairment_
No adjustment of dosage is required in patients with mild to severely
impaired renal function or in patients on chronic
dialysis i.e. haemodialysis and continuous ambulatory peritoneal
dialysis (see section 5.2 for more details).
There is insufficient data in patients with impaired liver function
(see section 4.3).
_Other special populations_
No adjustment of dosage is required in the elderly and in patients
with low bodyweight.
_Paediatric population_
Moxifloxacin is contraindicated in children and growing adolescents.
Efficacy and safety of moxifloxacin in children
and adolescents have not been established (see s